FDA.reportPublic FDA data

MAUDE MDR 4346800

MDR report key
4346800
Report number
2951238-2014-00613
Event key
0
Event type
3
Date of event
2014-10-02
Date received
2014-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NOEMI SCHAMBACH
Address
2400 RINGWOOD AVE. SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DUBERSTEIN PHENOL APPLICATORPHENOL APPLICATORGYRUS ACMI INC.KCJ130610130610R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-210

Event Narratives#

D

Patient 1

OLYMPUS WAS INFORMED THAT WHILE THE PHYSICIAN WAS REMOVING A ROCK FROM THE PATIENT'S LEFT EAR, THE TIP OF THE DEVICE BROKE OFF. THE PHYSICIAN FLUSHED THE PATIENT'S EAR WITH ANTIBIOTIC DROPS DURING IRRIGATION AND USED A GENTLE SUCTION. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT INJURY TO THE PATIENT.

N

Patient 1

THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.